Valvular & structural heart disease
Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial
Primary result · KCCQ-OS, mean between-group differenceResult — go to the resultMean difference 17.8 points 95% CI 13.0–22.5Authors' conclusion
Compared with OMT alone, treatment of patients with symptomatic and severe or greater TR with TTVR+OMT resulted in substantial improvement in patients' symptoms, function, and quality of life.
Study context
- Population
- Patients with symptomatic and severe or greater tricuspid regurgitation (mean age 79.2 years, 75.5% women)392 analysed
- Participants
- 400 patients
- Comparison
- Transcatheter tricuspid valve replacement (TTVR)+optimal medical therapy (OMT) vs OMT alone
- TTVR+OMTn = 259
- OMTn = 133reference
- Primary endpoint
- Change in health status (KCCQ-OS; SF-36)
- Follow-up
- 1 year
Methodological details2:1 randomisation, mixed-effects repeated-measures models
- 2:1 randomisation
- Mixed-effects repeated-measures models
Primary result
KCCQ-OS, mean between-group difference
Mean difference
17.8 points
95% CI 13.0–22.5
TTVR+OMTvs OMT
mean difference 17.8 points (95% CI 13.0–22.5)
As reported in the abstract
Further findings
| Outcome | Mean difference (points) (95% CI) | |
|---|---|---|
| KCCQ-OS, mean between-group difference · 30 days | 11.8 (7.4–16.3) | |
| KCCQ-OS, mean between-group difference · 6 months | 20.8 (16.1–25.5) | |
| −2002040Difference, points (linear scale) |
Alive and well (KCCQ-OS ≥60 points and no decline of ≥10 points from baseline) · 1 year
Treatment effect by tricuspid regurgitation (TR) severity (subgroup)
- Torrential TR
- 23.3
- Massive TR
- 22.6
- Severe TR
- 11.3
- Interaction P = 0.049
Original publication
Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial. J Am Coll Cardiol. Published 30 October 2024. doi:10.
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